Quantilex Plus XL Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Praziquantel 175 mg

Pyrantel Embonate 504 mg (equivalent to 175 mg pyrantel)

Febantel 525 mg

Excipients:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Lactose monohydrate,

Microcrystalline cellulose,

Magnesium stearate,

Colloidal anhydrous silica,

Croscarmellose sodium,

Sodium lauryl sulfate

Pork flavour

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Pharmaceutical form

Tablet A yellow-coloured oblong tablet with a breakline on both sides.

The tablets can be divided into equal parts.

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Pharmacological properties

Pharmacotherapeutic group:

ATC Vet Code: QP52AA51

5.1 Pharmacodynamic properties

This veterinary medicinal product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The veterinary medicinal product contains three active substances, as follows:

1. Febantel, a probenzimidazole

2. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative

3. Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.

This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.

The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against all adult and immature forms of these parasites.

Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites.

There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.

Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2 – 3 days later.

5.2 Pharmacokinetic particulars

Perorally administered praziquantel is absorbed almost completely from the intestinal tract. After absorption, the drug is distributed to all organs. Praziquantel is metabolised into inactive forms in the liver and secreted in bile. It is excreted within 24 hours to more than 95% of the administered dosage. Only traces of non-metabolised praziquantel are excreted.

Following administration of the veterinary medicinal product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.

The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine. Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.

Febantel is absorbed relatively rapidly and metabolised to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.

Following administration of the Veterinary medicinal product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.

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Target species

Dogs

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Indications

Treatment of mixed infections by nematodes and cestodes of the following species

Nematodes:

Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).

Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).

Whipworms: Trichuris vulpis (adults).

Cestodes:

Tapeworms: Echinococcus species (E. granulosus, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).

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Dosage

Oral Use.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

Dosage:

For treatment of dogs, 1 tablet per 35 kg body weight (15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel/kg body weight).

Dosages are as follows:

The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.

Tablets should be given as a single administration.

Part tablets should be discarded immediately or returned to the open blister until used.

If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

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Contraindications

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Do not use during the 1st and 2nd trimester of pregnancy (see section 4.7)

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Adverse reactions

Dogs:

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product.

Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

In the interests of good hygiene, persons administering the tablets directly to the dog, or by adding them to the dog’s food, should wash their hands afterwards.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

The veterinary medicinal product is effective against Echinococcus spp. which does not occur in all EU member states but are becoming more common in some. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (WOAH), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

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Use during pregnancy, lactation or lay

Pregnancy and Lactation:Teratogenic effects attributed to high doses of febantel administered during early pregnancy have been reported in rats, sheep and dogs.

The safety of the veterinary medicinal product has not been investigated during the 1st and 2nd trimester of pregnancy. Do not use in pregnant dogs during the 1st and 2nd trimester of pregnancy (see section 4.3).

A single treatment during the last trimester of pregnancy or during lactation has been demonstrated safe.

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Interactions

Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.

Concurrent use with other cholinergic compounds can lead to toxicity.

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Overdose

In safety studies, a single dose of 5 times the recommended dose of the combination of praziquantel, pyrantel embonate or greater gave rise to occasional vomiting.

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Special warnings

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

To minimise the risk of reinfestation and new infestation, excreta should be collected and properly disposed of for 24 hours following treatment.

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Withdrawal period

Not applicable.

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Incompatibilities

Not Applicable

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Immediate packaging

The veterinary medicinal product is presented in:

Blister packs made up of PVC/PE/PCTFE with 20µ hard tempered aluminium foil with 2, 4, 5, 6, 8, 10, 12, 14, 16, 18 or 20 tablets per blister.

The Blisters are packed into cartons containing either 2, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 40, 42, 44, 48, 50, 52, 56, 60, 64, 68, 70, 72, 76, 80, 84, 88, 92, 96, 98, 100, 104, 106, 108, 112, 116, 120, 140, 150, 180, 200, 204, 206, 208, 250, 280, 300, 500 or 1000 tablets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special temperature storage conditions.

Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the outer carton.

Keep the blister in the outer carton.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years Shelf life of half tablets: 14 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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Additional information

Vm 08749/5052

9 DATE OF FIRST AUTHORISATION

29 January 2015

10 DATE OF REVISION OF THE TEXT

July 2025

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

NFA-VPS

Gavin Hall Approved: 30 July 2025

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co. Galway

Ireland

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